FACT Invites You to Join Us for a Webinar in Support of World Cord Blood Day

Posted in :: 2020 Volume 8 :: Thursday, October 29th, 2020

In anticipation of World Cord Blood Day, FACT invites you to attend a special Cord Blood webinar on Monday, November 16, 2020 at 10:00 am ET, 15:00 GMT. The purpose of this webinar is to discuss the current progress using UM171-expanded cord blood transplantation, as well as to understand the effect of the COVID-19 pandemic on cord blood collection and transplantation in France. This webinar is 90-minutes, complimentary, and will be presented in French. Slides will be available in both English and French.

Presenters include:

  • Maude Dumont-Lagacé, PhD, a clinical scientist at ExCellThera Inc. (Canada)
  • Catherine Faucher, Md, clinical hematologist and currently in charge of the strategic pole “collection and transplantation of HSC” at the Agence de Biomédecine. (France)

FACT also encourages you to join the Save the Cord Foundation on November 17 for a free live virtual conference. The program will include introductory presentations for the public and academic lectures led by renowned researchers and transplant physicians on the latest advances and treatments using cord blood.

Instructions for joining the FACT Webinar on November 16:

  1. Log into Webinar: https://zoom.us/j/92269845238?pwd=SUZab2V3aTVpN3dPTkJYS0F6WDFIUT09
  2. Meeting ID: 922 6984 5238
  3. Passcode: WCBD

_____________________________________________

French Translation

En préparation de la Journée Mondiale du Sang de Cordon, FACT vous invite à participer à un webinaire spécial le lundi 16 Novembre 2020 à 10.00 ET, 15:00 GMT. L’objectif de ce webinaire est de discuter les progrès récents liés à l’utilisation de la méthode d’expansion de cellules UM171 en transplantation de sang de cordon, et également de comprendre l’effet de la pandémie COVID-19 sur la collecte et la transplantation de sang de cordon en France. Ce webinaire de 90 minutes est gratuit et sera présenté en français. Les orateurs seront:

  • Maude Dumont-Lagacé, PhD, Spécialiste en Sciences Cliniques à ExCellThera Inc (Canada)
  • Catherine Faucher, MD, Hématologue Clinicienne, actuellement en charge du pôle “Prélèvement et greffes de CSH” à l’Agence de biomédecine (France)

FACT vous encourage également à rejoindre la Fondation Save the Cord le 17 Novembre pour une conférence virtuelle gratuite. Le programme comprendra des présentations d’introduction pour le public et des présentations académiques par des chercheurs et médecins transplanteurs renommés, sur les dernières avancées et les traitements utilisant le sang de cordon.

Instructions pour rejoindre le webinaire le 16 Novembre:

  1. Connexion au webinaire: https://zoom.us/j/92269845238?pwd=SUZab2V3aTVpN3dPTkJYS0F6WDFIUT09
  2. Identification de la conférence: 922 6984 5238
  3. Mot de passe: WCBD

FACT Inspection & Accreditation Virtual Workshop an Interactive and Educational Success

Posted in :: 2020 Volume 8 :: Thursday, October 29th, 2020

FACT’s first Inspection & Accreditation Virtual Workshop, hosted on September 21, 2020, was a great success! FACT thanks the workshop chairs, Ngaire Elwood, PhD and Joseph Schwartz, MD, MPH; the FACT Education Committee, the presenters, and the attendees for bringing energy and enthusiasm to this important educational event. A culture of quality is as important now as it ever was, and we enjoyed being “with” the FACT community again!

Please Complete the Workshop Evaluation

If you attended the workshop, please tell us everything! We are always striving to provide a great educational experience.  As part of this, we would appreciate feedback on FACT’s first virtual workshop so we can improve and make the next virtual event even better.

Complete virtual workshop evaluation

Summary

Workshop Registrants

The Foundation for the Accreditation of Cellular Therapy hosted its first virtual inspection and accreditation workshop on September 21, 2020.  The workshop included two tracks, apheresis collection and cord blood banking. Attendance included 165 workshop registrants, 35 FACT staff members and Matrix Maxx staff members, and 19 workshop presenters and moderators. The breakdown of the 165 attendees is illustrated below:

Registrants from 18 different countries attended, including:

Lunch with Leaders

Participants were able to ask any question to FACT leaders during the Lunch with Leaders session.

Favorite Parts of the Day

In addition to these favorite parts of the day, attendees enjoyed feeling connected with the international FACT community during this challenging year and felt the workshop was one of the most interactive and engaging virtual conferences. Attendees also felt that the workshop was comprehensive and educational despite being virtual.

Workshop Programming

The workshop included pre-recorded presentations, live question and answer sessions, interactive activities requiring audience participation, and a live tour of an apheresis unit and cord blood bank.

Participants were able to ask questions at any time via the workshop chat feature.  Each track included a moderator; Dr. Dennis Gastineau moderated the apheresis track and Dr. Kim Kasow moderated the cord blood track.   Dr. Gastineau and Dr. Kasow were able to monitor presentation chat questions and interact with the presenters to ensure all questions were answered.

Participants joined in polling sessions, which allowed them to participate in analyzing case studies on both workshop tracks.


Calling All Cord Blood Banking Professionals!

Posted in :: 2020 Volume 7 :: Thursday, September 17th, 2020

There is still time to register for the FACT Inspection & Accreditation Virtual Workshop scheduled for Monday, September 21, 2020, from 8:00 am to 3:00 pm CT. Register for the workshop today!

Workshop presenters have a special message for all cord blood banking professionals below.

We hope to see you at FACT’s very first virtual workshop on September 21st!


Calling All Apheresis Professionals!

Posted in :: 2020 Volume 7 :: Thursday, September 17th, 2020

There is still time to register for the FACT Inspection & Accreditation Virtual Workshop scheduled for Monday, September 21, 2020, from 8:00 am to 3:00 pm CT. Register for the workshop today!

Workshop presenters have a special message for all apheresis professionals below.

We hope to see you at FACT’s very first virtual workshop on September 21st!


Upcoming Quality Management Series Module 10: Validation

Posted in :: 2020 Volume 7 :: Thursday, September 17th, 2020

Process Validation
Presented by Jacklyn Stentz MT (ASCP) and Deborah Griffin MS, ASQ CPGP
October 14, 2020, 11:00 am ET, 15:00 GMT

Presenters will discuss the following:

  • Range to validate (where to start and when to stop), variables and extreme scenarios
  • Process validations (to include Bone Marrow process)
  • Verification: when is it needed

Register now

Software Validation

Presented by Robyn Rodwell, PhD and Guy Klamer, PhD
December 2, 2020, 4:00 pm ET, 21:00 GMT

Dr. Rodwell and Dr. Klamer will discuss the use of software validation as a substitute for paper, to make decisions, to perform calculations, or to create or store information used in critical procedures. Other topics include:

  • Critical electronic systems under the control of the organization (facility)
  • Spreadsheets
  • Vendor and organization responsibilities

Register now

Program Perspective on Validation
TBA

Register for the entire series to receive a 15% discount! 

Module 10 includes all of the upcoming webinars and the recording of the first webinar:

Validation Overview
Presented by Nicole Prokopishyn, PhD
August 19, 2020, 11:00 am ET, 15:00 GMT

Dr. Prokopishyn discussed the differences among Validation, Verification, and Qualification, including Process Validation of immune effector cells, cord blood banking, apheresis, clinical, and processing.

Purchase recording now


Registration is Open for the FACT Inspection & Accreditation Virtual Workshop!

Posted in :: 2020 Volume 6 :: Monday, August 24th, 2020

September 15, 2020 – 8:00 am to 3:00 pm CDT/13:00 to 20:00 GMT

 

When one door closes, another one opens – and FACT’s first ever Inspection & Accreditation Virtual Workshop makes these words ring true! We wish all of our stakeholders good health and safety, and are pleased to offer a new workshop format to allow us all to come together again. After all, learning never ends.

The workshop co-chairs, Ngaire Elwood, PhD and Joseph Schwartz, MD, MPH, have been working hard with the FACT Education Committee and the international panel of presenters to offer an elegant and interactive learning experience. Registrants can choose either the cord blood or apheresis track, and will also have the opportunity to ask questions directly to leaders in accreditation, cord blood, or apheresis in the Lunch with Leaders session.

Following a combination of presentations, recordings, activities, games, and discussions; workshop attendees will leave the event being able to:

  • Describe the accreditation process.
  • Evaluate documentation to ensure compliance.
  • Organize the on-site inspection process.
  • Plan a program tour.
  • Identify strategies to support a successful inspection.
  • Practice evaluating deficiencies.

The year 2020 has made it even more obvious that a culture of quality is critical to providing quality patient care. With no travel required and low registration fees, several colleagues at your institutions can register for the event, thereby developing an even deeper understanding of FACT accreditation at your program.

“See” you at the workshop!

View workshop details

See workshop agenda

Register for the workshop


Upcoming Educational Events

Posted in :: 2020 Volume 6 :: Friday, August 21st, 2020

Register now:

Bringing a Stand-Alone Immune Effector Cell therapy Program into FACT Compliance

 

Upcoming Quality Management Series Module 10: Validation

Process Validation
Presented by Jacklyn Stentz MT (ASCP) and Deborah Griffin MS, ASQ CPGP
October 14, 2020, 11:00 am ET, 15:00 GMT

Presenters will discuss the following:

  • Range to validate (where to start and when to stop), variables and extreme scenarios
  • Process validations (to include Bone Marrow process)
  • Verification: when is it needed

Register now

Software Validation

Presented by Robyn Rodwell, PhD and Guy Klamer, PhD
December 2, 2020, 4:00 pm ET, 21:00 GMT

Dr. Rodwell and Dr. Klamer will discuss the use of software validation as a substitute for paper, to make decisions, to perform calculations, or to create or store information used in critical procedures. Other topics include:

  • Critical electronic systems under the control of the organization (facility)
  • Spreadsheets
  • Vendor and organization responsibilities

Register now

Program Perspective on Validation

TBA

Register for the entire series to receive a 15% discount! 

Module 10 includes all of the upcoming webinars and the recording of the first webinar:

Validation Overview

Presented by Nicole Prokopishyn, PhD

August 19, 2020, 11:00 am ET, 15:00 GMT

Dr. Prokopishyn discussed the differences among Validation, Verification, and Qualification, including Process Validation of immune effector cells, cord blood banking, apheresis, clinical, and processing.


SAVE THE DATE: FACT Announces Virtual Inspection & Accreditation Workshop

Posted in :: 2020 Volume 5 :: Wednesday, July 29th, 2020


Quality Management Series, Module 10: Validations

Posted in :: 2020 Volume 5 :: Wednesday, July 29th, 2020

The Quality Management Series Module 10 includes four sessions focused on Validation including:

Validation Overview
Presented by Nicole Prokopishyn, PhD
August 19, 2020, 11:00 am ET, 15:00 GMT

Dr. Prokopishyn will discuss the difference between Validation, Verification, and Qualification, including Process Validation of immune effector cells, cord blood banking, apheresis, clinical, and processing.

Register now

Process Validation
Presented by Jacklyn Stentz MT (ASCP) and Deborah Griffin MS, ASQ CPGP
October 14, 2020, 11:00 am ET, 15:00 GMT

Presenters will discuss the following:

  • Range to validate (where to start and when to stop), variables and extreme scenarios
  • Process validations (to include Bone Marrow process)
  • Verification: when is it needed

Register now

Software Validation
Presented by Robyn Rodwell, PhD and Guy Klamer, PhD
December 2, 2020, 4:00 pm ET, 21:00 GMT

Dr. Rodwell and Dr. Klamer will discuss the use of software validation as a substitute for paper, to make decisions, to perform calculations, or to create or store information used in critical procedures. Other topics include:

  • Critical electronic systems under the control of the organization (facility)
  • Spreadsheets
  • Vendor and organization responsibilities

Register now

Program Perspective on Validation
TBA

Register for the entire module to receive a 15% discount! QM Series Module 10: Validations


FACT-CBA Webinar: The Effect of the COVID-19 Pandemic on Cord Blood Banking

Posted in :: 2020 Volume 4 :: Thursday, June 18th, 2020

The Effect of the COVID-19 Pandemic on Cord Blood Banking
Monday, June 22, 2020, at 9:00 am ET, 13:00 GMT

Presenters will discuss how cord blood banks have been managing through the COVID-19 pandemic:

Heidi Elmoazzen, PhD
Canadian Blood Services’ Cord Blood Bank & Stem Cell Manufacturing

Dr. Elmoazzen will discuss the impact of the COVID-19 Pandemic on stem cell transplantation in Canada including Canadian Blood Services’ Cord Blood Bank Stem Cell Registry and Public Cord Blood Bank.

Roger Horton, PhD
Anthony Nolan Cord Blood Bank, United Kingdom

Dr. Horton will summarize the demand for UK cords between Jan-May 2019 and 2020, and compare both years to give an idea on the impact of the pandemic on operations. He will provide detail on collections, processing, storage, distribution, product protection, and staffing to demonstrate how Anthony Nolan has adapted or mitigated each issue. Where possible Dr. Horton will compare Anthony Nolan practices with other European partners.

Arvin Faundo, MD
Cordlife Group Limited, Singapore

Dr. Faundo will discuss how the coronavirus pandemic is affecting the operations of the Cordlife Group Limited bank and identify the pandemic-related problems that are specific to private or family cord blood banks.

Donna Regan MT(ASCP), SBB
NMDP

Donna will present statistics before and through the pandemic (CB orders, shipments, transplants) and the promotion of services that supported this activity. She will also highlight the unique steps taken by the registry to support unrelated transplant, not least of which is leveraging the cord blood story to cryopreserve all unrelated products prior to patient conditioning.

Lydia Foeken, LN
WMDA, Executive Director

Register now:
The Effect of the COVID-19 Pandemic on Cord Blood Banking


New Immune Effector Cellular Therapy Webinar: Bringing a Stand-Alone Immune Effector Cell Therapy Program into FACT Compliance

Posted in :: 2020 Volume 4 :: Thursday, June 18th, 2020

Register now:
Bringing a Stand-Alone Immune Effector Cell therapy Program into Compliance


Integration of Immune Effector Cellular Therapy into a FACT-Accredited Transplant Program presented by Dr. Carlos Bachier

Posted in :: 2020 Volume 3 :: Friday, April 24th, 2020


Canceled: FACT Cellular Therapy Collection Inspection and Accreditation Workshop

Posted in :: 2020 Volume 3 :: Friday, April 24th, 2020

The American Society for Apheresis (ASFA) Board of Directors has decided not to proceed with the ASFA 2020 Annual Meeting, originally scheduled for May 6 – 9, 2020 in Austin, Texas due to the coronavirus (COVID-19) outbreak.

For the same considerations, the associated FACT Cellular Therapy Collection Inspection and Accreditation Workshop scheduled for May 6, 2020 has also been cancelled.

The ASFA Board of Directors is currently assessing the feasibility of rescheduling the Annual Meeting for later this year. If ASFA reschedules the annual meeting, the FACT workshop will also be rescheduled. Your payment will be applied to the new FACT Collection Inspection and Accreditation Workshop date. If the meeting is not rescheduled for 2020, your payment can be applied to the FACT workshop at the 2021 ASFA Meeting. If you prefer to receive a refund, please contact the FACT Business Manager, Jay Ann Witt at jawitt@unmc.edu.

The health and well-being of our cellular therapy community, volunteers, staff, and patients is our utmost concern. We look forward to seeing you at our next workshop. If you have questions, please do not hesitate to contact the FACT Office.


Canceled: FACT Cord Blood Inspection and Accreditation Workshop at ISCT Annual Meeting

Posted in :: 2020 Volume 3 :: Friday, April 24th, 2020

The International Society of Cell and Gene Therapy (ISCT) has decided not to proceed with the ISCT 2020 in-person Annual Meeting, originally scheduled May 27 – 30, 2020 in Paris, France due to the coronavirus (COVID-19) pandemic. The ISCT 2020 Annual Meeting is rescheduled to take place virtually on May 28 and 29, 2020.  The virtual meeting will be accessible remotely and on-demand, including live and recorded sessions that are certified for CME and CMLE accreditation in addition to networking events, poster halls, and 1-on-1 partnering opportunities. The highly curated ISCT 2020 virtual meeting program will leverage state-of-the-art virtual meeting technology to provide the full ISCT Annual Meeting experience that you expect from ISCT.  For more details visit: http://www.isct2020.com/.

Because there will not be an in-person ISCT meeting, the associated FACT Cord Blood Inspection and Accreditation Workshop scheduled for May 26, and the ISCT-FACT Quality Boot Camp scheduled for May 27, 2020 have been cancelled.

If the FACT workshop is not rescheduled as a virtual session, your payment can be applied to the FACT workshop at the 2021 ISCT Meeting. If you prefer to receive a refund, please contact the FACT Business Manager, Jay Ann Witt at jawitt@unmc.edu.


FACT Cord Blood Inspection and Accreditation Workshop at the 2020 Cord Blood Connect International Congress on Hold

Posted in :: 2020 Volume 3 :: Friday, April 24th, 2020

Given the rapidly evolving COVID-19 pandemic, a temporary moratorium has been placed on pre-registrations for the Cord Blood Connect international congress, scheduled for Sept. 10-12 in Miami Beach. The acceptance of abstracts also has been suspended while CBA leaders continue to assess the viability of this year’s congress.

For the same considerations, registrations for the FACT Cord Blood Inspection and Accreditation Workshop scheduled for September 9, 2020 are also on a temporary hold.

Options being evaluated include re-scheduling, as well as alternatives for the in-person conference. Updates will be provided by FACT as information is made available.


FACT Announces Immune Effector Cellular Therapy Webinar Series

Posted in :: 2020 Volume 1 :: Monday, January 27th, 2020

The FACT Education Committee and Immune Effector Cell Task Force have developed a series of webinars on Immune Effector Cellular Therapy.  Six webinars are planned throughout 2020 and include the following topics:

The State of FACT Immune Effector Cell Therapy Accreditation Today presented by Dr. Patrick Hanley
Wednesday, March 4, 2020
11:00 am ET, 16:00 GMT

Dr. Patrick Hanley, Director of GMP for Immunotherapy at Children’s National Health System Blood and Marrow Transplant Program, will present the State of FACT Immune Effector Cell Therapy Accreditation Today. Dr. Hanley will discuss the growth and expected direction of IEC Accreditation and describe the major concepts addressed the FACT IEC Standards. He will also explain various methods of compliance, as well as compare requirements between FACT and commercial manufacturers.

Register now

Labeling and Chain of Custody for IEC Products presented by Dr. Sarah Nikiforow
Wednesday, April 22, 2020
11:00 am ET, 15:00 GMT

Dr. Sarah Nikiforow from Dana-Farber Cancer Institute / Cell Manipulation Core Facility, will present  Labeling and Chain of Identity and Custody for IEC Products.  Dr. Nikiforow will review the IEC Standards related to labeling and chain of identity and custody and explain FACT expectations for clinical trial research product labeling and chain of custody from bench to bedside.  In addition, she will describe how ISBT 128 coding and labeling can be used with commercial cellular therapy products.

Register now

Integration of Immune Effector Cellular Therapy into a FACT-Accredited Transplant Program presented by Dr. Carlos Bachier
June 17, 2020
11:00 am ET, 15:00 GMT

Dr. Carlos Bachier, Program Director and Processing Facility Director at Sarah Cannon Blood and Marrow Transplant Program in Nashville, will present Integration of Immune Effector Cellular Therapy into a FACT-Accredited Transplant Program.  Dr. Bachier will begin by discussing the requirements for transplantation and immune effector cellular therapy.  He will highlight opportunities and challenges when incorporating immune effector cellular therapy into an existing Quality Management Plan, and provide steps that can be taken to incorporate immune effector cellular therapy into a transplant program.

Register now

Other sessions within this series include:

  • Bringing a Stand-Alone Immune Effector Cell Therapy Program into FACT Compliance (Date/time TBD)
  • IEC Inspector Training (Date/time TBD)
  • Data Reporting and REMS Compliance (Date/time TBD)

Final Webinar in the Quality Management Series, Auditing

Posted in :: 2020 Volume 1 :: Monday, January 27th, 2020

February 5, 2020
3:00 pm ET, 20:00 GMT

Join FACT for the final webinar in the ninth Quality Management Series, Auditing.  Phillip Johnson, MMedSc(Path), Production Manager at Queensland Cord Blood Bank at the Mater, Sylvia Dulan, RN, MSN, MBA, PMP, HCT Regulatory and Quality Management Specialist at City of Hope Hematopoietic Cell Transplantation Program, and Ann Wilson, MHA, MT(ASCP)SB , Lab and Quality Manager at Scott & White Autologous Transplant Program, will give an overview of their program’s audit process and how they write audit reports.

Register now

The first three webinars within the module are available for download in the FACT store:

  1. QM Series 9: Auditing: Planning and Executing
  2. QM Series 9: Auditing: Summarizing and Evaluating the Data
  3. QM Series 9: Auditing: Performing follow-up to assess the effectiveness of the actions implemented on correcting the errors

Stay tuned for the next QM Series 10, Validations!  Topics include Validation Overview, Process Validation, Software Validation, and Program Perspectives on Validation.